Sexual ViolenceNCT03392597
Preventing Sexual Violence Among Middle School Boys With a Strengths-Based Curriculum
A study testing Brothers as Allies and Programming-as-Usual in people with Sexual Violence, run by New York State Department of Health at 1 site in United States.
Trial summary
This research will examine if participation in a strengths-based curriculum, the Brothers as Allies program adapted from the Council for Boys and Young Men, reduces risk for future sexual violence perpetration among middle school-aged boys in New York State. Read more about this study
- Who is it for?
- Ages 12 to 14 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Violence
- What is being tested?
- Brothers as Allies and Programming-as-Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2017to 29 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants must be males of middle school age (12-14 years), participating in afterschool/youth programming at one of the intervention or control sites.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Planned Parenthood of Central and Western New York
Rochester, New York, 14605
Greta A Niu, PhD, 585-546-2771 ext. 362, greta.niu@ppcwny.org
About this study
Official title: Testing the Efficacy of a Strengths-Based Curriculum to Reduce Risk for Future Sexual Violence Perpetration Among Middle School Boys
This research will examine if participation in a strengths-based curriculum, the Brothers as Allies program adapted from the Council for Boys and Young Men, reduces risk for future sexual violence perpetration among middle school-aged boys in New York State.
Read the detailed description
Using a longitudinal waitlist control design, this study will evaluate the efficacy of a strengths-based curriculum, the Brothers as Allies program from the Council for Boys and Young Men, to reduce risk for future sexual violence perpetration with middle school-aged boys (ages 12-14) in New York State. This research will examine if participation in the program decreases negative behaviors (such as later sexual violence perpetration and sexual aggression) and increases positive behaviors (such as bystander intervention and caring/cooperative behaviors) amongst program participants, in comparison to participants who participate in programming-as-usual. Other potential moderators and outcomes linked to sexual violence victimization and sexual assault perpetration (including attitudes related to gender roles, acceptance of sexual violence, and interpersonal relationships) will also be measured. The research team will also assess the extent to which the curriculum, when implemented with fidelity and quality, leads to improved relationships and stronger connections with adults in afterschool or other community-based youth-program settings. All participants will complete surveys at baseline, immediate post-intervention, and at 3 and 6 months post-intervention. Finally, the investigators will also assess the implementation factors which impact the efficacy of this program, such as fidelity and quality of program delivery. The research team hypothesizes participants in the Brothers as Allies program will show post-intervention decreased sexual violence perpetration, less acceptance of sexual violence, less stereotypic gender role attitudes, greater youth-adult connectedness, and increased bystander intervention, caring, and cooperation behaviors compared to peers in the non-intervention group. In order to complete this work, the research team is collaborating with the New York Rape Prevention and Education (RPE)-funded Regional Centers for Sexual Violence Prevention and a Research Advisory Board of community members and professionals from New York State.
- Conditions
- Sexual Violence
- Being tested
- Brothers as Allies, Programming-as-Usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brothers as AlliesBehavioural
Strengths-based group approach to promote boys' and young men's safe and healthy passage through the pre-teen and adolescent years.
Programming-as-UsualBehavioural
Usual afterschool programming.
| Study group | Role | What they receive |
|---|---|---|
| Brothers as Allie | Experimental | Brothers as Allies is a strengths-based group approach to promote boys' and young men's safe and healthy passage through the pre-teen and adolescent years by addressing rigid beliefs and norms about masculinity that are harmful to the health, safety, relationships and opportunities of boys and young men. Groups of six to ten boys of similar age and development meet weekly with one or two facilitators for 1.5 to 2 hours for ten or more weeks. Meetings include warm up activities, an opportunity for check-in, experiential activities that address gender relevant topics (e.g., group challenges, games, skits, role plays), and a reflection and group dialogue component. Receives: Behavioral: Brothers as Allies |
| Programming-as-Usual | Active comparator | Usual programming implemented in afterschool programs. Receives: Behavioral: Programming-as-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual violence perpetration (Koss et al., 2006)
This will be measured by items from a widely used measure of sexual violence perpetration behaviors
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start26 Jul 2017
- Primary completion24 Jul 2020 (estimated)
- Study completion29 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Waitlist control design in which matched sites are randomly assigned to an intervention or waitlist control group to implement and evaluate the Brothers as Allies program. Intervention groups will participate in the Brothers as Allies program from the Council for Boys and Young Men. Waitlist control groups will participate in programming-as-usual until implementation with the intervention groups is complete, at which point they will receive the intervention. All participants will complete surveys at baseline, immediate post-intervention, and at 3 and 6 months post-intervention.
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Department of Health
- Sponsor type
- Other government
- Collaborators
- Cornell University
- Responsible party
- Principal investigator, Janis Whitlock, Cornell University
- Investigators
- Janis Whitlock, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392597
- Sponsor's protocol ID
- CE002834
- Status last verified
- Mar 2019
- First submitted
- 3 Aug 2017
- Last updated
- 15 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of a Strengths-Based Curriculum to Reduce Risk for Future Sexual Violence Perpetration Among Middle School Boys
- ClinicalTrials.gov ID
- NCT03392597
- Acronym / sponsor ID
- CE002834
- Conditions
- Sexual Violence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- New York State Department of HealthOther government
- Collaborators
- Cornell University
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 24 Jul 2020 (estimated)
- Study completion
- 29 Sep 2020 (estimated)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will examine if participation in a strengths-based curriculum, the Brothers as Allies program adapted from the Council for Boys and Young Men, reduces risk for future sexual violence perpetration among middle school-aged boys in New York State.
Detailed description
Using a longitudinal waitlist control design, this study will evaluate the efficacy of a strengths-based curriculum, the Brothers as Allies program from the Council for Boys and Young Men, to reduce risk for future sexual violence perpetration with middle school-aged boys (ages 12-14) in New York State. This research will examine if participation in the program decreases negative behaviors (such as later sexual violence perpetration and sexual aggression) and increases positive behaviors (such as bystander intervention and caring/cooperative behaviors) amongst program participants, in comparison to participants who participate in programming-as-usual. Other potential moderators and outcomes linked to sexual violence victimization and sexual assault perpetration (including attitudes related to gender roles, acceptance of sexual violence, and interpersonal relationships) will also be measured. The research team will also assess the extent to which the curriculum, when implemented with fidelity and quality, leads to improved relationships and stronger connections with adults in afterschool or other community-based youth-program settings. All participants will complete surveys at baseline, immediate post-intervention, and at 3 and 6 months post-intervention. Finally, the investigators will also assess the implementation factors which impact the efficacy of this program, such as fidelity and quality of program delivery. The research team hypothesizes participants in the Brothers as Allies program will show post-intervention decreased sexual violence perpetration, less acceptance of sexual violence, less stereotypic gender role attitudes, greater youth-adult connectedness, and increased bystander intervention, caring, and cooperation behaviors compared to peers in the non-intervention group. In order to complete this work, the research team is collaborating with the New York Rape Prevention and Education (RPE)-funded Regional Centers for Sexual Violence Prevention and a Research Advisory Board of community members and professionals from New York State.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist control design in which matched sites are randomly assigned to an intervention or waitlist control group to implement and evaluate the Brothers as Allies program. Intervention groups will participate in the Brothers as Allies program from the Council for Boys and Young Men. Waitlist control groups will participate in programming-as-usual until implementation with the intervention groups is complete, at which point they will receive the intervention. All participants will complete surveys at baseline, immediate post-intervention, and at 3 and 6 months post-intervention.
| Arm | Type | Receives |
|---|---|---|
| Brothers as Allie | Experimental | Behavioral: Brothers as AlliesBrothers as Allies is a strengths-based group approach to promote boys' and young men's safe and healthy passage through the pre-teen and adolescent years by addressing rigid beliefs and norms about masculinity that are harmful to the health, safety, relationships and opportunities of boys and young men. Groups of six to ten boys of similar age and development meet weekly with one or two facilitators for 1.5 to 2 hours for ten or more weeks. Meetings include warm up activities, an opportunity for check-in, experiential activities that address gender relevant topics (e.g., group challenges, games, skits, role plays), and a reflection and group dialogue component. |
| Programming-as-Usual | Active comparator | Behavioral: Programming-as-UsualUsual programming implemented in afterschool programs. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants must be males of middle school age (12-14 years), participating in afterschool/youth programming at one of the intervention or control sites.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brothers as AlliesStrengths-based group approach to promote boys' and young men's safe and healthy passage through the pre-teen and adolescent years. | Behavioural | Brothers as Allie |
| Programming-as-UsualUsual afterschool programming. | Behavioural | Programming-as-Usual |
Primary outcome
Sexual violence perpetration (Koss et al., 2006)
Time frame: 3 months
This will be measured by items from a widely used measure of sexual violence perpetration behaviors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janis Whitlock, PhD principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brothers as Allies and Programming-as-Usual in people with Sexual Violence, run by New York State Department of Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ann-Margret Foley (518-474-0535, ann-margret.foley@health.ny.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual violence perpetration (Koss et al., 2006) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.